Balloon catheter

ABSTRACT

A balloon catheter comprises a balloon, an outer tube connected to a proximal end of the balloon, an inner tube disposed inside the outer tube and having a distal end attached to a distal end of the balloon, a protruded-depressed portion formed on an outer periphery of the inner tube, and a core wire disposed between the outer tube and the inner tube. The core wire has a bulged portion sandwiched between the outer tube and a depressed portion of the protruded-depressed portion. The balloon catheter can transmit a force from the core wire to both the outer tube and the inner tube regardless of whether the force is generated by pushing or pulling a proximal end portion of the balloon catheter. Additionally, the core wire can move appropriately to maintain the flexibility of the balloon catheter even when the balloon catheter bends.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 15/876,432filed Jan. 22, 2018, which in turn is a continuation of application Ser.No. 14/944,449 filed Nov. 18, 2015, which claims priority to JapaneseApplication No. 2015-047146 filed Mar. 10, 2015. The disclosure of theprior applications is hereby incorporated by reference herein in itsentirety.

BACKGROUND

The disclosed embodiments relate to a medical device. Specifically, thedisclosed embodiments relate to a balloon catheter.

Balloon catheters, which are used for expanding a stenosis site and thelike in a lumen such as a blood vessel, are traditionally known.

A balloon catheter mainly comprises a balloon as an expanding object, anouter tube attached to a proximal end portion of the balloon, and aninner tube disposed inside an inner cavity of the outer tube and havinga distal end portion attached to a distal end portion of the balloon.

The outer tube is designed for allowing an expansion liquid such asphysiological saline to flow through a cavity defined between the outertube and the inner tube in order to expand the balloon. The inner tubeis designed so that a guide wire may be inserted into the inner tube inorder to guide the balloon catheter to an affected area.

In general, a balloon catheter is used as follows: an operator such as aphysician holds the balloon catheter at a proximal end portion of theballoon catheter and pushes a distal end portion of the balloon catheterinto a blood vessel. Therefore, in order to position the balloon in adesired location of an affected area, excellent pushability into theaffected area and excellent maneuverability of the distal portion arerequired.

Japanese Patent Application Laid-Open No. 2012-20077 describes a ballooncatheter comprising a core wire inserted between a catheter shaft (anouter tube) and an inner shaft (an inner tube) in addition to theconfiguration described above, wherein the core wire is sandwichedbetween the outer tube and the inner tube.

According to Japanese Patent Application Laid-Open No. 2012-20077, theballoon catheter can supposedly improve the pushability of the ballooncatheter without the need for a complicated process by simplysandwiching the core wire between the outer tube and the inner tube.

However, the balloon catheter described in Japanese Patent ApplicationLaid-Open No. 2012-20077 has the following problems. Although thepushability of the catheter may be improved, in a case where theproximal end portion of the balloon catheter is pulled, the resultingpulling force cannot be transmitted to the balloon catheter through thecore wire. Further, in a case where a pushing force against the proximalend portion of the balloon catheter is very strong, the core wire willmove between the outer tube and the inner tube in the distal direction.Therefore, the core wire will be fixed between the outer tube and theinner tube, interfering with the flexibility of the balloon catheter.

SUMMARY

The disclosed embodiments address the above problems. An objective ofthe disclosed embodiments is to provide a balloon catheter in which afunction for transmitting a force from a core wire to both an outer tubeand an inner tube can be maintained regardless of whether the force isgenerated by pushing or pulling the proximal end portion of the ballooncatheter, and in which the core wire is allowed to move appropriately tomaintain the flexibility of the balloon catheter even when the ballooncatheter bends.

In order to address the aforementioned problems, the disclosedembodiments include a balloon catheter comprising a balloon, an outertube connected to a proximal end of the balloon, an inner tube disposedinside the outer tube and having a distal end connected to a distal endof the balloon, a protruded-depressed portion (i.e., a convex-concavetextured portion) formed on an outer periphery of the inner tube, and acore wire disposed between the outer tube and the inner tube. The corewire has a bulged portion (i.e., an enlarged portion) sandwiched betweenthe outer tube and a depressed portion of the protruded-depressedportion. Therefore, a force can be transmitted from the core wire toboth the outer tube and the inner tube regardless of whether the forceis generated by pushing or pulling the proximal end portion of theballoon catheter. Additionally, the bulged portion of the core wire canmove appropriately between depressed portions of the protruded-depressedportion to maintain the flexibility of the balloon catheter even whenthe balloon catheter bends.

The protruded-depressed portion may be formed by winding a wire aroundthe outer periphery of the inner tube to form a coil body having a largepitch (that is, a coil body in which adjacent windings of the wire arespaced apart from each other when the balloon catheter is in an unbentstate). Therefore, this simple configuration can allow the force ofpushing and/or pulling to be transmitted from the core wire to both theouter tube and the inner tube, and a kink in the inner tube can beprevented in addition to the advantageous effects described above.

A surface of the coil body may be coated with a resin so that the outerperiphery of the inner tube forms streamlined (smoothed) protrusions anddepressions along the shape of the wire of the coil body. Therefore, thebulged portion can move more smoothly in addition to the advantageouseffects described above.

The balloon catheter of the disclosed embodiments may satisfy therelationship Dc>Da>Db, wherein Da represents a distance between an innerwall of the outer tube and a base of each of the depressed portions ofthe protruded-depressed portion in a radial direction of the ballooncatheter, Db represents a distance between the inner wall of the outertube and an apex of each of the protruded portions of theprotruded-depressed portion in the radial direction of the ballooncatheter, and Dc represents an outer diameter of the bulged portion.Therefore, when the proximal end portion of the balloon catheter ispushed and/or pulled, the resulting force can be better transmitted fromthe core wire to both the outer tube and the inner tube in addition tothe advantageous effects described above.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic overall view of a balloon catheter according tothe disclosed embodiments.

FIG. 2 shows a partial enlarged view of region A of FIG. 1.

FIG. 3 shows a schematic overall view of a balloon catheter according tothe disclosed embodiments.

FIG. 4 shows a partial enlarged view of region B of FIG. 3.

FIG. 5 shows a schematic overall view of a balloon catheter according tothe disclosed embodiments.

FIG. 6 shows a partial enlarged view of region C of FIG. 5.

FIG. 7 shows an enlarged view of a main section of a balloon catheteraccording to the disclosed embodiments.

FIG. 8 shows a diagram illustrating movement of a bulged portion of acore wire of the balloon catheter of FIG. 7.

DETAILED DESCRIPTION OF EMBODIMENTS

The configuration of a balloon catheter according to the disclosedembodiments will be described below with reference to the Figures. Ineach of FIGS. 1 to 8, the left side corresponds to a distal side (afront side) that is to be inserted into the body, and the right sidecorresponds to a proximal side (a base side) that is to be operated byan operator such as a physician. For parts in common with eachconfiguration, description will be omitted and the same referencenumbers will be assigned in the figures.

FIG. 1 shows a schematic overall view of a balloon catheter according tothe disclosed embodiments, and FIG. 2 shows a partial enlarged view ofregion A of FIG. 1.

A balloon catheter 10 shown in FIG. 1 comprises a balloon 30, an outertube 20 connected to a proximal end portion of the balloon 30, an innertube 40 inserted inside the outer tube 20 and having a distal endconnected to a distal end of the balloon 30, a hypotube 23 connected toa proximal end of the outer tube 20, a core wire 60 inserted between theouter tube 20 and the inner tube 40 and having a proximal end connectedto a distal end portion of the hypotube 23, and a connector 70 connectedto a proximal end portion of the hypotube 23.

The balloon 30 comprises an expanding part 31 that expands due to thepressure of a liquid injected inside, a distal attachment part 32connected to the distal end of a distal end portion 40 a of the innertube 40, and a proximal attachment part 33 connected to an outerperiphery of a distal end of the outer tube 20. The expanding part 31can be expanded with the pressure of the liquid injected inside to forman inner cavity 34 and to have a bag-like shape. Further, the innercavity 34 of the balloon 30 communicates with an inner lumen 28 of theouter tube 20.

The outer tube 20 is a tubular body having a distal end outer tube 21located on a distal side of the outer tube 20 and a proximal end outertube 22 located on a proximal side of the outer tube 20. The inner lumen28 extends continuously from the distal end outer tube 21 to theproximal end outer tube 22. Further, a liquid for expanding the balloon30 can flow through the inner lumen 28 of the outer tube 20.

The distal end outer tube 21 and the proximal end outer tube 22 may beformed from a resin such as polyamide, polyamide elastomer, polyolefin,polyester, or polyester elastomer, for example.

The distal end outer tube 21 comprises a body tube 21 a located on adistal side of the distal end outer tube 21, and a port tube 21 blocated on a proximal side of the distal end outer tube 21. The proximalattachment part 33 of the balloon 30 is connected to an outer peripheryof a distal end of the body tube 21 a.

The port tube 21 b has an inner cavity in communication with the innerlumen 28 and an opening (a proximal end opening) 44 in which a proximalend portion 40 b of the inner tube 40 described below is open to theenvironment. Note that the port tube 21 b may be formed from a resinharder than that of the body tube 21 a.

The inner tube 40 is a tubular body having a distal end portion 40 a andthe proximal end portion 40 b and is inserted coaxially with the outertube 20 into the inner lumen 28 of the distal end outer tube 21 of theouter tube 20. The inner tube 40 has an inner lumen 41 in which a guidewire not shown in the figure may be inserted.

Further, a protruded-depressed portion 45 comprising protruded portions45 a and depressed portions 45 b, which are of spiral or annular shapesin a longitudinal direction of the balloon catheter 10, is formed on anouter periphery of the inner tube 40 throughout the entire length of theinner tube 40. Note that the inner tube 40 may be formed of the sameresin as the distal end outer tube 21 and the proximal end outer tube22.

The distal end portion 40 a of the inner tube 40 protrudes from a distalend of the distal end outer tube 21, and a tip 42 formed of a soft resinmay be attached to a distal end of the distal end portion 40 a.

The hypotube 23 is a metal tubular body. The proximal end outer tube 22is connected to an outer periphery of the distal end portion of thehypotube 23, and the connector 70 is attached to the proximal endportion of the hypotube 23. Further, a proximal end portion 60 b of thecore wire 60 described below is connected to an inside of the distal endportion of the hypotube 23.

As a material of the hypotube 23, for example, a superelastic alloy suchas stainless steel or a Ni—Ti alloy may be used.

The core wire 60 comprises a distal end portion 60 a, the proximal endportion 60 b, and a bulged portion 80 connected to a distal end of thedistal end portion 60 a and having a diameter larger than a wirediameter of the distal end portion 60 a.

The proximal end portion 60 b of the core wire 60 is connected to theinside of the distal end portion of the hypotube 23 by joining meanssuch as welding, adhesives, and the like, and the bulged portion 80disposed at the distal end portion 60 a of the core wire 60 issandwiched between the outer tube 20 and one of the depressed portions45 b of the protruded-depressed portion 45.

The connector 70 is a resin tubular member. When a liquid is suppliedfrom an indeflator (not shown) attached to a proximal end of theconnector 70, the liquid enters the inner cavity 34 of the balloon 30from the hypotube 23 through the inner lumen 28 to expand the balloon30.

The tip 42 is a tapered tubular member having an outer diameter thatgradually decreases in the distal direction, and having a distal endopening 43 at a distal end of the tip 42. The tip 42 may be formed of aresin softer than that of the distal end portion 40 a of the inner tube40.

Further, two radiopaque markers 35 a and 35 b separated by apredetermined distance are attached to the distal end portion 40 a ofthe inner tube 40 inside of the expanding part 31 of the balloon 30.

A case where the balloon catheter 10 is used in a procedure forexpanding a stenosis site in the coronary artery of the heart will bedescribed based on the above configuration.

A guide wire is inserted into the coronary artery of the heart having astenosis site as a treatment target before operation of the ballooncatheter 10 begins. First, an operator inserts a proximal end of thisguide wire through the distal end opening 43 of the balloon catheter 10and passes it through the inner lumen 41 of the inner tube 40, and thenretrieves the guide wire through the proximal end opening 44.Subsequently, while holding the guide wire, a proximal end portion ofthe balloon catheter 10 is pushed in the distal direction to advance theballoon catheter 10 into the patient's blood vessel.

The pushing force with which an operator pushes is first transmitted tothe outer tube 20 and the core wire 60 from the hypotube 23. In thiscase, the bulged portion 80 disposed at the distal end portion 60 a ofthe core wire 60 is sandwiched between the outer tube 20 and one of thedepressed portions 45 b of the protruded-depressed portion 45, and thusthe pushing force transmitted to the outer tube 20 and the core wire 60is also transmitted to the inner tube 40.

Further, since the bulged portion 80 is sandwiched, but not fixed,between the outer tube 20 and one of the depressed portions 45 b of theprotruded-depressed portion 45, the bulged portion 80 is capable ofmoving in both the distal and proximal directions as needed. Forexample, the bulged portion 80 can move to a distally adjacent one ofthe depressed portions 45 b in a case where the balloon catheter 10bends toward the side of the core wire 60 due to the serpentine state ofa patient's blood vessel. On the other hand, in a case where the ballooncatheter 10 bends toward the opposite side of the core wire 60, thebulged portion 80 can move to a proximally adjacent one of the depressedportions 45 b. Therefore, the flexibility of the balloon catheter 10 canbe maintained.

If the bulged portion 80 was both sandwiched and fixed (that is,adhered) between the outer tube 20 and one of the depressed portions 45b of the protruded-depressed portion 45, the balloon catheter 10 wouldbe difficult to bend due to the rigidity of the core wire 60 and thelike in a case where the balloon catheter 10 bends toward the side ofthe core wire 60 or the opposite side of the core wire 60 depending onthe serpentine state of a patient's blood vessel. In contrast, theballoon catheter 10 in which the bulged portion 80 is not fixed in placewill bend flexibly depending on the serpentine state of a patient'sblood vessel since the rigidity of the core wire 60 will not interferewith the maneuverability of the balloon catheter 10 through a curvedvessel.

Further, the bulged portion 80 moves to the distally adjacent one of thedepressed portions 45 b when the pushing force to the core wire 60exceeds a predetermined value, and thus an excessive force will not betransmitted to a distal end of the balloon catheter 10. An operator cantherefore safely operate the balloon catheter 10.

Subsequently, an operator positions the balloon 30 at a stenosis site asa target site while observing markers 35 a and 35 b under radioscopy,and then supplies a liquid from an indeflator (not shown) connected tothe connector 70. At this time, the liquid flows into the inner lumen 28of the outer tube 20, and flows out from the distal end of the distalend outer tube 21 into the inner cavity 34 of the balloon 30 to expandthe balloon 30, which in turn expands the stenosis site at the sametime.

After expanding the stenosis site with the balloon 30, the operatordischarges the liquid from the balloon 30 with the indeflator. That is,the liquid flows out of the inside of the balloon 30 and is dischargedthrough the inner lumen 28 of the outer tube 20. Then, the ballooncatheter 10 is pulled out of the patient's body to complete theprocedure.

A pulling force is also first transmitted to the outer tube 20 and thecore wire 60 from the hypotube 23 when the operator pulls the ballooncatheter 10 out of the patient's body. In this case, the bulged portion80 disposed at the distal end portion 60 a of the core wire 60 issandwiched between the outer tube 20 and one of the depressed portions45 b of the protruded-depressed portion 45, and thus the pulling forcetransmitted to the outer tube 20 and the core wire 60 is alsotransmitted to the inner tube 40, enabling smooth withdrawal of theballoon catheter 10 from the patient's body.

In the case of the balloon catheter 10, the following operationaleffects can be achieved.

(1) The balloon catheter 10 comprises the balloon 30, the outer tube 20connected to the proximal end of the balloon 30, the inner tube 40disposed inside the outer tube 20 and having a distal end connected tothe distal end of the balloon 30, the protruded-depressed portion 45formed on the outer periphery of the inner tube 40, and the core wire 60disposed between the outer tube 20 and the inner tube 40. The core wire60 has the bulged portion 80 sandwiched between the outer tube 20 andone of the depressed portions 45 b of the protruded-depressed portion45. Therefore, a force can be transmitted from the bulged portion 80 ofthe core wire 60 to both the outer tube 20 and the inner tube 40regardless of whether the force is generated by pushing or pulling theproximal end portion of the balloon catheter 10.

(2) Even if the balloon catheter 10 bends, the bulged portion 80 of thecore wire 60 can move appropriately between the depressed portions 45 bof the protruded-depressed portion 45, and thus the flexibility of theballoon catheter 10 can be maintained.

FIG. 3 also shows a schematic overall view of a balloon catheteraccording to the disclosed embodiments. FIG. 4 shows a partial enlargedview of region B of FIG. 3.

A balloon catheter 100 shown in FIG. 3 has an inner tube different fromthat of the balloon catheter 10 described above. That is, an inner tube140 of the balloon catheter 100 has a distal end portion 140 a and aproximal end portion 140 b, and is a tubular body which is insertedcoaxially with the outer tube 20. In particular, the inner tube 140 isinserted into the inner lumen 28 of the distal end outer tube 21 of theouter tube 20. The inner tube 140 has an inner lumen 141 in which aguide wire not shown in the figure may be inserted.

Further, a protruded-depressed portion 145 comprising protruded portions145 a and depressed portions 145 b is formed by spirally winding, in alongitudinal direction of the balloon catheter 100, a metal wire 150with a circular cross section to form a coil body. The metal wire 150 iswound on an outer periphery of the inner tube 140 over the entire lengthof the inner tube 140. The metal wire 150 is wound with a large pitchsuch that adjacent windings of the metal wire 150 are spaced apart fromeach other when the balloon catheter 100 is in an unbent state.

As described above, the metal wire 150 with a circular cross section isspirally wound in the longitudinal direction of the balloon catheter 100to form a coil body having a large pitch in order to form theprotruded-depressed portion 145. However, a resin wire may instead beused to form the protruded-depressed portion 145, or a metal wire with arectangular cross section or a resin wire with a rectangular crosssection may instead be used to form the protruded-depressed portion 145.Further, two or more metal or resin wires with a circular or rectangularcross section may be used to form the protruded-depressed portion 145,or one twisted wire formed by twisting together two or more metal orresin wires with a circular cross section may be used to form theprotruded-depressed portion 145. Further, two or more twisted wiresformed by twisting together two or more metal or resin wires with acircular cross section may be used to form the protruded-depressedportion 145.

The bulged portion 80 disposed at the distal end portion 60 a of thecore wire 60 is sandwiched between the outer tube 20 and one of thedepressed portions 145 b of the protruded-depressed portion 145. In acase where the balloon catheter 100 as described above is used in aprocedure for expanding a stenosis site in the coronary artery of theheart, a pushing and/or pulling force can be transmitted from the bulgedportion 80 of the core wire 60 to both the outer tube 20 and the innertube 140, and a kink in the inner tube 140 can be prevented by utilizingthis simple configuration of the protruded-depressed portion 145 formedby winding the metal wire 150 around the outer periphery of the innertube 140 to form a coil body having a large pitch.

FIG. 5 shows a schematic overall view of a balloon catheter according tothe disclosed embodiments. FIG. 6 shows a partial enlarged view ofregion C of FIG. 5.

A balloon catheter 200 shown in FIG. 5 has an inner tube different fromthat of the balloon catheter 10 described above. That is, a metal wire250 with a rectangular cross section is spirally wound in a longitudinaldirection of the balloon catheter 200 on an outer periphery of an innertube 240 to form a coil body with a large pitch that covers the entirelength of the inner tube 240. A surface of the metal wire 250 is coatedwith a resin 260 to form streamlined protrusions and depressions on anouter periphery of the inner tube 240 a long the shape of the metal wire250 with a rectangular cross section. The protrusions and depressionsform a protruded-depressed portion 245 comprising protruded portions 245a and depressed portions 245 b. That is, the streamlined protrusions anddepressions correspond to the protruded portions 245 a and the depressedportions 245 b, respectively, having smoothed surfaces.

As a resin material for forming the coating, a resin such as polyamide,polyamide elastomer, polyolefin, polyester, or polyester elastomer, forexample, may be used.

As described above, the metal wire 250 with a rectangular cross sectionis spirally wound in the longitudinal direction of the balloon catheter200 to form a coil body having a large pitch, thereby forming theprotruded-depressed portion 245. However, a resin wire may instead beused to form the protruded-depressed portion 245, or a metal wire with acircular cross section or a resin wire with a circular cross section mayinstead be used to form the protruded-depressed portion 245. Further,two or more metal or resin wires with a circular or rectangular crosssection may be used to form the protruded-depressed portion 245, or onetwisted wire formed by twisting together two or more metal or resinwires with a circular cross section may be used to form theprotruded-depressed portion 245. Further, two or more twisted wiresformed by twisting together two or more metal or resin wires with acircular cross section may be used to form the protruded-depressedportion 245.

The bulged portion 80 disposed at the distal end portion 60 a of thecore wire 60 is sandwiched between the outer tube 20 and one of thedepressed portions 245 b of the protruded-depressed portion 245. In acase where the balloon catheter 200 is used in a procedure for expandinga stenosis site in the coronary artery of the heart, the bulged portion80 can move smoothly, in addition to the advantageous effects describedabove, because the surface of the metal wire 250 of the coil body iscoated with the resin 260 so that the outer periphery of the inner tube240 forms streamlined protrusions and depressions along the shape of themetal wire with a rectangular cross section to form theprotruded-depressed portion 245 comprising the protruded portions 245 aand the depressed portions 245 b.

FIG. 7 shows an enlarged view of a main section of a balloon catheter300 according to the disclosed embodiments. FIG. 8 shows a diagramillustrating the movement of a bulged portion 82. The balloon catheter300 satisfies the relationship Dc >Da >Db, wherein Da represents adistance between an inner wall of the outer tube 20 and a base of eachof the depressed portions 245 b in a radial direction of the ballooncatheter 300, Db represents a distance between the inner wall of theouter tube 20 and an apex of each of the protruded portions 245 a in theradial direction of the balloon catheter 300, and Dc represents an outerdiameter of the bulged portion 82. Therefore, the transferability of apushing or pulling force from the core wire 60 to both the inner tube240 and the outer tube 20 can be further improved.

Further, as shown in FIG. 8, when the balloon catheter 300 bends towardthe side of the core wire 60 depending on the serpentine state of apatient's blood vessel, the bulged portion 82 can move to a distallyadjacent one of the depressed portions 245 b (toward the left side inthe figure) to maintain the flexibility of the balloon catheter 300. Onthe other hand, when the balloon catheter 300 bends toward the oppositeside of the core wire 60, the bulged portion 82 can move to a proximallyadjacent one of the depressed portions 245 b (toward the right side inthe figure) to maintain the flexibility of the balloon catheter 300.

Note that although FIG. 8 describes the movement of the bulged portion82 in the distal and proximal directions (toward the left and rightsides of the figure, respectively), it is apparent that the bulgedportion 80 described above can also move in a similar fashion.

Note that although the balloon catheters 10, 100, 200, 300 have beendescribed in the context of use for the treatment of a blood vessel ofthe heart, they may be used in various procedures such as those forexpanding a blood vessel of a lower limb or for expanding a dialysisshunt.

Further, the balloon catheters 10, 100, 200, 300 have the bulged portion80, 82 provided at the distal end portion 60 a of the core wire 60.However, the bulged portion 80, 82 may be provided at a middle portionof the core wire 60.

What is claimed is:
 1. A catheter comprising: an outer tube; an innertube disposed inside the outer tube; a protruded-depressed portionprovided on an outer periphery of the inner tube, theprotruded-depressed portion including a plurality of protruded portionsand a plurality of depressed portions alternately arranged along alongitudinal direction of the inner tube; and a core wire disposedbetween the outer tube and the inner tube, and having a bulged portion,wherein a periphery of the bulged portion is disposed between a firstprotruded portion and a second protruded portion, which are two of theplurality of protruded potions that are located adjacent each other. 2.The catheter according to claim 1, wherein the bulged portion isprovided at a distal end of the core wire.
 3. The catheter according toclaim 1, wherein the bulged portion is freely movable relative to theouter tube and the first and second protruded portions.
 4. The catheteraccording to claim 1, wherein: the bulged portion is connected to adistal end of a distal end portion of the core wire; and a diameter ofthe bulged portion is larger than a wire diameter of the distal endportion of the core wire.